Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
52
Countries
2
Sites
5
Advanced Solid Tumors
Key facts
- Sponsor
- Merck Healthcare KGaA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 25 Feb 2025 → ongoing
- Decision date (initial)
- 2024-11-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513687-26-00
- ClinicalTrials.gov
- NCT06641908
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10075333 | Soft tissue sarcoma | 100000004864 |
| 20.0 | PT | 10018336 | Glioblastoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Healthcare KGaA
- Sponsor organisation
- Merck Healthcare KGaA
- Address
- Frankfurter Strasse 250
- City
- Darmstadt
- Postcode
- 64293
- Country
- Germany
Scientific contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Public contact point
- Organisation
- Merck Healthcare KGaA
- Contact name
- Global Regulatory Affairs
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 13 | 1 |
| France | Ongoing, recruiting | 13 | 4 |
| Rest of world
United States, Japan, Switzerland, United Kingdom
|
— | 26 | — |
Investigational sites
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Antoine Lacassagne
Oncologie médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centre Oscar Lambret
Oncologie médicale, 3 Rue Frederic Combemale, 59000, Lille
Institut Bergonie
Oncologie médicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-02-25 | 2025-03-06 | |||
| France | 2025-03-20 | 2025-04-08 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-31 | Belgium | Acceptable with conditions 2024-11-25
|
2024-11-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-12 | Belgium | Acceptable 2025-02-03
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-21 | Acceptable | 2025-06-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-05 | Belgium | Acceptable 2026-01-28
|
2026-01-29 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-20 | Belgium | Acceptable 2026-03-30
|
2026-03-30 |